VKF-RAD7ARAD7A

Radical-7 Operator's Manual www.masimo.com 1 Masimo The Radical-7 operating instructions provide the necessary information for proper operation of all models of the Radical-7 Pulse CO-Oximeter system. There may be information provided in this manual that is not relevant for your system. General knowledge of pulse oximetry and an understanding of the features and functions of the Radical-7 are prerequisites for its proper use. Do not operate the Radical-7 without completely reading and understanding the instructions in this manual. NOTICE: Purchase or possession of this instrument does not carry any express or implied license to use this instrument with replacement parts which would, alone or in combination with this instrument, fall within the scope of one of the patents relating to this instrument. Caution Federal law restricts this device to sale by or on the order of a physician. Wireless Radio FCC ID: VKF-RAD7A, IC: 7362A-RAD7A Masimo Corporation 40 Parker Irvine, CA 92618, USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com EU authorized representative for Masimo Corporation: MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany Medical electrical equipment with respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1 Patents: www.masimo.com/patents.htm © 2012 Masimo Corporation ®, Adaptive Probe Off Detection®, APOD®, Discrete Saturation Transform®, DST®, FastSat®, FST®, Masimo®, Pulse Oximeter®, PVI®, rainbow®, SatShare®, SET®, Signal Extraction Technology®, Signal IQ®, SpCO®, SpHb®, SpMet® are federally registered trademarks of Masimo Corporation. Adaptive Threshold Alarm™, In Vivo Adjustment™, Pleth Variability Index™, Radical-7™, Rainbow Acoustic Monitoring™, rainbow Resposable™, RDS™, RRa™, RRp™,SafetyNet™, SpOC™ are trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. The use of the trademarks PATIENT SAFETYNET and PSN is under license from University HealthSystem Consortium. www.masimo.com 3 Masimo Contents About this Manual -------------------------------------------------------------------------------------------7 Product Description, Indications for Use, Contraindications, and Features ---------------------- 9 Product Description ------------------------------------------------------------------------------------- 9 Indications for Use ------------------------------------------------------------------------------------- 10 Contraindications -------------------------------------------------------------------------------------- 10 Safety Information, Warnings, and Cautions ---------------------------------------------------------- 11 Parameter Related Safety Information, Warnings, and Cautions ------------------------------ 11 Device Related Safety Information, Warnings, and Cautions----------------------------------- 14 Electrical Safety Information, Warnings, and Cautions ----------------------------------------- 18 Alarm Related Safety Information, Warnings, and Cautions ---------------------------------- 20 Sensor Related Safety Information, Warnings, and Cautions ---------------------------------- 21 Chapter 1: Technology Overview ------------------------------------------------------------------------ 23 Signal Extraction Technology (SET) ---------------------------------------------------------------- 23 rainbow Pulse CO-Oximetry Technology ----------------------------------------------------------- 25 rainbow Acoustic Monitoring (RAM) Technology ------------------------------------------------- 29 Chapter 2: Radical-7 Descriptions --------------------------------------------------------------------- 33 General System Description ------------------------------------------------------------------------- 33 Functionality of the Radical-7 ------------------------------------------------------------------------ 34 Handheld ----------------------------------------------------------------------------------------------- 35 Standalone ---------------------------------------------------------------------------------------------- 37 Monitor Interface With SatShare ------------------------------------------------------------------- 40 Chapter 3: Setup ------------------------------------------------------------------------------------------- 41 Unpacking and Inspection --------------------------------------------------------------------------- 41 Docking Station Power Requirements -------------------------------------------------------------- 41 Setting Up the Docking Station --------------------------------------------------------------------- 41 Initial Battery Charging ------------------------------------------------------------------------------- 42 Setting Up for Philips, Agilent, or HP VueLink ---------------------------------------------------- 42 Setting Up for SpaceLabs Flexport ------------------------------------------------------------------ 43 Setting Up and Using SatShare --------------------------------------------------------------------- 44 Chapter 4: Operation -------------------------------------------------------------------------------------- 45 Using the Touchscreen and Buttons ---------------------------------------------------------------- 45 Radical-7 Contents www.masimo.com 4 Masimo Using Screen Lock ------------------------------------------------------------------------------------- 46 Using the Home Button ------------------------------------------------------------------------------ 46 Navigating the Radical-7 ----------------------------------------------------------------------------- 47 About the Display View ------------------------------------------------------------------------------- 48 Sensitivity Modes Overview -------------------------------------------------------------------------- 55 Changing Sensitivity Modes ------------------------------------------------------------------------- 56 Accessing the Main Menu…

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WTD 13.4.9 FCC Compliance Opinion MASI0151 Information about the Applicant Grantee (Company Name) Masimo Corporation FCC Contact Person Eugene Kim Address 40 Parker City, State, Zip Irvine, CA 92618 Job Number MASI0151 Model RADICAL-7 FCC ID VKF-RAD7A Agent Michael Clark Approval Type Original Equipment Class DTS Digital Transmission System, NII Unlicensed National Information Infrastructure Tx DSS Direct Sequence Spreadspectrum Rule Part 15.247, 15.407 Overview The RAD7A is a pulse CO-Oximeter which contains an 802.11 a/b/g radio to allow connecting to a wireless network. Confidentiality requested for allowed files. Request is properly addressed and referenced. Short term confidentiality requested. Recommendation All items have been resolved and completed to my satisfaction; therefore I recommend this application for approval. Signature Dave Tolman, TCB Committee 1/19/2015

February 04-2014 Dear Application Examiner: Masimo Corporation is submitting this application for the certification of their model RAD7A Pulse CO-Oximeter. It is an LCD touch screen based display handheld pulse CO-Oximeter with a model RDS series docking station. It contains a radio interface to allow wireless connection to Patient Safety Net and other wireless systems. The technical reports and exhibits demonstrate compliance with FCC Part 15.247, 15.407. The applicant’s radio is compliant with FCC Part 15.247 and 15.407. FCC ID: VKF-RAD7A Please treat the contents of this application in a confidential manner. Your efforts in reviewing this application are greatly appreciated. Regards, Michael Clark

Request for Confidentiality Letter-FCC 3-05-2014 NWEMCTCB To whom it may concern, We hereby respectfully request that under the provision of 47 CFR 0.459 and 0.457(d) the documents listed below and attached with this application for certification be provided with confidential status.  Schematics.pdf  Operational Description.pdf  Frequency Block Diagrams.pdf Any exhibit / information for which we have requested confidentiality, but which may not be accorded such treatment by the FCC, should be returned to us. The documents listed above contain trade secrets that are treated as confidential by us. Substantial competitive harm to us could result should they be made available to the public. Sincerely, Michael Clark Engineer Senior Test R&D Instruments

Ethertronics’ Prestta series of Isolated Magnetic Dipole™ (IMD) trace antennas address the challenges facing today’s product designers. IMD’s high perfor- mance and isolation characteristics offer better con- nectivity and minimal interference. IMD antennas can be used in a variety of devices:  Notebook Computers  Access Points  WiFi enabled Televisions & Monitors PRODUCT: WLAN Prestta TM WLAN Embedded Antenna 2.4/4.9/5.2/5.8 GHz (802.11 a/b/g/n + Japan) Part No. 9000129 & 9000130 TECHNOLOGY ADVANTAGES Prestta WLAN antennas use patented IMD technology in a trace configuration to provide high performance. IMD antennas requires a smaller design keep-out area, carry lower program development risk which yields a quicker time-to-market, without sacrificing RF performance. Stays in Tune IMD antenna technology provides superior RF field containment, resulting in less interaction with surrounding components. Ethertronics IMD antennas resist de-tuning; providing a robust radio link regardless of the usage position. KEY BENEFITS SERVICE AND SUPPORT Extensive RF Experience  Our WLAN antennas are supported by documentation, and when needed, by the expertise of RF engineers who have integrated hundreds of antenna designs into wireless devices. Global Operations & Design Support  Ethertronics’ global operations supports an integrated network of design centers that can take projects from concept to production. END USER ADVANTAGES Unique Form Factors Support Advanced Industrial Designs  Smaller, more efficient IMD embedded antennas break through restrictive design rules and provide new free- dom in component placement. Superior Range & Signal Strength  Better antenna function means longer range and great- er sensitivity to critically precise signals—delivering greater customer satisfaction while building brand loy- alty. DESIGN ADVANTAGES Quicker Time-to-Market  By optimizing antenna size, performance and emis- sions, customer and regulatory specifications are more easily met. Greater Flexibility  Ethertronics’ first-in-class IMD technology enables you to develop concept designs that are more advanced and that deliver superior performance in reception- critical applications.  Multiple cable lengths to fit a variety of devices. RoHS Compliant  Ethertronics’ antennas are fully compliant with the European RoHS Directive 2002/95/EC. ETHERTRONICS 5501 Oberlin Drive, Suite 100, San Diego, CA. 92121, USA www.ethertronics.com Tel +(1) 858.550.3820 | fax +(1) 858.550.3821 | contact: [email protected] PRODUCT: WLAN a/b/g/n + Japan - P/N 9000129 & 9000130 Dimensions 42.0 x 8.0 x 0.8 mm Weight 0.4 g Cable / Connector U.fl Connector, 1.13mm diameter coaxial cable. Cable Length 100mm cable Main Antenna Substrate P/N 9000129: Based on PCB substrate P/N 9000130: Based on FPC substrate Mechanical Specification Ethertronics’ Internal (Embedded) Antenna Specifications. Below are the typical specs for a WLAN application. Electrical Specification Typical Characteristics (In reference device housing made of PC/ABS plastic) WLAN a/b/g/n + Japan Antenna (GHz) 2.390-2.490 b, g 4.900-5.100 Japan 5.150-5.350 a 5.35-5.90 a Peak Gain in dBi 2.0 4.0 5.0 6.0 Efficiency 65% 72% 72% 65% Return Loss in dB < -10.0 < -10.0 < -10.0 < -10.0 Feed Point Impedance 50 Ω unbalanced (other if required) Return Loss in dB Efficiency in % ETHERTRONICS 5501 Oberlin Drive, Suite 100, San Diego, CA. 92121, USA www.ethertronics.com Tel +(1) 858.550.3820 | fax +(1) 858.550.3821 | contact: [email protected] Ethertronics’ Internal (Embedded) Antenna Specifications. Below are the typical specs for a WLAN application. 2.4GHz 5GHz © 2013 Ethertronics. All rights reserved. Ethertronics, the Ethertronics logo, shaping antenna technology, Prestta, Savvi, Tavvel, Isolated Magnetic Dipole and the iMD logo are trademarks of Ethertronics. All other trademarks are the property of their respective owners. Specifications subject to change and are dependent upon actual implementation. 9000129 & 9000130 1May2013 PRODUCT: WLAN a/b/g/n + Japan - P/N 9000129 & 9000130

Masimo Corporation RAD7A SAR Evaluation Report #: MASI0204 Evaluated to the following SAR Specification: FCC 2.1093:2014 Report Prepared By Northwest EMC Inc. NORTHWEST EMC – (888) 364-2378 – www.nwemc.com California – Minnesota – Oregon – New York – Washington WTD 12.5.23 CERTIFICATE OF TEST Last Date of Test: March 19, 2014 Masimo Corporation Model: RAD7A Applicable Standard Test Description Specification Test Method Pass/Fail SAR Evaluation FCC 2.1093:2014 FCC 15.247:2014 IEEE Std 1528:2003 Pass FCC KDB 447498 D01 v05r02 FCC KDB 248227 D01 v01r02 FCC KDB 865664 D01 v01r03 and D02 v01r01 Highest SAR Values: Frequency Bands (GHz) Body (W/kg) Limit (W/kg) Exposure Environment 1g 1g 2.4 0.054 1.6 General Population 5.0 Excluded Deviations From Test Standards None Approved By: Don Facteau, IS Manager NVLAP Lab Code: 200630-0 This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. Product compliance is the responsibility of the client, therefore the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. This Report may only be duplicated in its entirety. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. Report No. MASI02042/54 REV 2012.08.02 REVISION HISTORY Revision Number Description Date Page Number 00 None Barometric Pressure The recorded barometric pressure has been normalized to sea level. Report No. MASI02043/54 REV 2012.05.24 ACCREDITATIONS AND AUTHORIZATIONS United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC Guide 65 as a product certifier. This allows Northwest EMC to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada IC - Recognized by Industry Canada as a Certification Body (CB). Certification chambers and Open Area Test Sites are filed with IC. European Union European Commission – Validated by the European Commission as a Conformity Assessment Body (CAB) under the EMC directive and as a Notified Body under the R&TTE Directive. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea KCC / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Hong Kong OFTA – Recognized by OFTA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. Russia GOST – Accredited by Certinform VNIINMASH, CERTINFO, SAMTES, and Federal CHEC to perform EMC and Hygienic testing for Information Technology products to GOST standards. SCOPE For details on the Scopes of our Accreditations, please visit: http://www.nwemc.com/accreditations/ Report No. MASI02044/54 REV 2013.01.07 LOCATIONS Oregon Labs EV01-12 22975 NW Evergreen Pkwy Hillsboro, OR 97124 (503) 844-4066 California Labs OC01-13 41 Tesla Irvine, CA 92618 (949) 861-8918 New York Labs WA01-04 4939 Jordan Rd. Elbridge, NY 13060 (315) 685-0796 Minnesota Labs MN01-08 9349 W Broadway Ave. Brooklyn Park, MN 55445 (763) 425-2281 Washington Labs NC01-05,SU02,SU07 19201 120 th Ave. NE Bothell, WA 98011 (425) 984-6600 VCCI A- 0108 A- 0029 A- 0109 A- 0110 Industry Canada 2834D-1, 2834D-2 2834B-1, 2834B-2, 2834B-3 2834E-1 2834C-1 Report No. MASI02045/54 WTD 12.5.23 PRODUCT DESCRIPTION Client and Equipment Under Test (EUT) Information Company Name: Masimo Corporation Address: 40 Parker City, State, Zip: Irvine, CA 92618 Test Requested By: Michael Clark Model: RAD7A First Date of Test: February 26, 2014 Last Date of Test: March 19, 2014 Receipt Date of Samples: February 26, 2014 Equipment Design Stage: Production Equipment Condition: No Damage Information Provided by the Party Requesting the Test Functional Description of the EUT (Equipment Under Test): The EUT is the Masimo Model RAD7A Pulse CO-Oximeter containing an 802.11 a/b/g radio. The RAD7A is a handheld pulse CO-Oximeter with a LCD display. The radio interface allows wireless connection to Patient Safety Net and other wireless systems. The RAD7A is only used in a clinic or hospital environment. The hardware design limits wireless transmission to patient telemetry data only. No other type of data transmission is possible. Kirby Dotson, Manager Instrument Hardware at Masimo, attests that the maximum duty cycle is about 6%: “ The software sends 120bytes @ 62.5 Hz for 7500 bytes per second or 60K bits/sec. Worst duty cycle will be when in 1.1Mbit/sec mode which is 60K/1.1M for a duty cycle of about 6%.” The RAD7A uses one Isolated Magnetic Dipole™ (IMD) trace antenna located in the center / top half of the unit (see EUT photos). The frequency range of the 802.11a/b/g radio in the RAD7A: • 2412 – 2462 MHz • 5180 – 5240 MHz • 5745 – 5825 MHz In normal operation, the RAD7A can be placed in the Masimo Model RDS series docking station. This provides battery charging and wired connection to other devices. In this configuration, it will be used 20cm or greater from the user’s head or torso and can be considered a mobile device. However, when removed from the RDS docking station, it can be used in a stand-alone configuration. Primarily, it will be used as a handheld device, but it is also possible for the RAD7A to be placed next to the patient’s torso. No body worn accessories are sold or approved by Masimo, so a worst case s…

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This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. This Report may only be duplicated in its entirety Masimo Corporation RAD7A/Radical 7 V2 FCC 15.207:2014 FCC 15.247:2014 Report # MASI0234.2 NVLAP Lab Code: 200676-0 WTD 13.9.30 CERTIFICATE OF TEST Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. Last Date of Test: August 29, 2014 Masimo Corporation Model: RAD7A/Radical 7 V2 Radio Equipment Testing Standards Specification Method FCC 15.207:2014 ANSI C63.10:2009 FCC 15.247:2014 ANSI C63.10:2009 Results Method Clause Test Description Applied Results Comments 6.2 AC Powerline Conducted Emissions Yes Pass 6.5, 6.6 Spurious Radiated Emissions Yes Pass 6.7 Spurious Conducted Emissions Yes Pass 6.9.1 Occupied Bandwidth Yes Pass 6.10.1 Output Power Yes Pass 7.7.2 Channel Separation Yes Pass 7.7.3 Number of Hopping Channels Yes Pass 7.7.4 Dwell Time Yes Pass 7.5 Duty Cycle Yes N/A Characterization of radio operation. 7.7.9 Band Edge Compliance Yes Pass 7.7.9 Band Edge Compliance- Hopping Mode Yes Pass Deviations From Test Standards None Approved By: Victor Ratinoff, Operations Manager REV 2012.08.02 REVISION HISTORY Revision Number Description Date Page Number 00 None Barometric Pressure The recorded barometric pressure has been normalized to sea level. REV 2014.08.11 ACCREDITATIONS AND AUTHORIZATIONS United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC Guide 65 as a product certifier. This allows Northwest EMC to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada IC - Recognized by Industry Canada as a Certification Body (CB). Certification chambers and Open Area Test Sites are filed with IC. European Union European Commission – Validated by the European Commission as a Conformity Assessment Body (CAB) under the EMC directive and as a Notified Body under the R&TTE Directive. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIP / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFTA – Recognized by OFTA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. SCOPE For details on the Scopes of our Accreditations, please visit: http://www.nwemc.com/accreditations/ REV 2013.03.8 MEASUREMENT UNCERTAINTY Measurement Uncertainty When a measurement is made, the result will be different from the true or theoretically correct value. The difference is the result of tolerances in the measurement system that cannot be completely eliminated. To the extent that technology allows us, it has been our aim to minimize this error. Measurement uncertainty is a statistical expression of measurement error qualified by a probability distribution. A measurement uncertainty estimation has been performed for each test per our internal quality document WP 342. The estimation is used to compare the measured result with its "true" or theoretically correct value. The expanded measurement uncertainty (K=2) for each test is listed below. Our measurement data meets or exceeds the measurement uncertainty requirements of the applicable specification; therefore, the test data can be compared directly to the specification limit to determine compliance. The calculations for estimating measurement uncertainty are based upon ETSI TR 100 028 (or CISPR 16-4-1 as applicable), and are available upon request. The following table represents the Measurement Uncertainty (MU) budgets for each of the tests that may be contained in this report. Test + MU - MU Frequency Accuracy (Hz) 0.12 -0.01 Amplitude Accuracy (dB) 0.49 -0.49 Conducted Power (dB) 0.41 -0.41 Radiated Power via Substitution (dB) 0.69 -0.68 Temperature (degrees C) 0.81 -0.81 Humidity (% RH) 2.89 -2.89 Field Strength (dB) 3.80 -3.80 AC Powerline Conducted Emissions (dB) 2.94 -2.94 REV 2013.06.28 FACILITIES Oregon Labs EV01-12 22975 NW Evergreen Pkwy Hillsboro, OR 97124 (503) 844-4066 California Labs OC01-13 41 Tesla Irvine, CA 92618 (949) 861-8918 New York Labs NY01-04 4939 Jordan Rd. Elbridge, NY 13060 (315) 685-0796 Minnesota Labs MN01-08 9349 W Broadway Ave. Brooklyn Park, MN 55445 (763) 425-2281 Washington Labs NC01-05,SU02,SU07 19201 120 th Ave. NE Bothell, WA 98011 (425) 984-6600 VCCI A-0108 A-0029 A-0109 A-0110 Industry Canada 2834D-1, 2834D-2 2834B-1, 2834B-2, 2834B-3 2834E-1 2834F-1 NVLAP NVLAP Lab Code: 200630-0 NVLAP Lab Code: 200676-0 NVLAP Lab Code: 200761-0 NVLAP Lab Code: 200881-0 NVLAP Lab Code: 200629-0 WTD 13.9.30 PRODUCT DESCRIPTION Client and Equipment Under Test (EUT) Information Company Name: Masimo Corporation Address: 40 Parker City, State, Zip: Irvine, CA 92618 Test Requested By: Michael Clark Model: RAD7A/Radical 7 V2 First Date of Test: August 28, 2014 Last Date of Test: August 29, 2014 Receipt Date of Samples: January 19, 2014 Equipment Design Stage: Production Equipment Condition: No Damage Information Provided by the Party Requesting the…

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This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. This Report may only be duplicated in its entirety Masimo Corporation RAD7A/Radical 7 V2 FCC 15.207:2014 FCC 15.247:2014 Report # MASI0234 NVLAP Lab Code: 200676-0 WTD 13.9.30 CERTIFICATE OF TEST Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. Last Date of Test: February 07, 2014 Masimo Corporation Model: RAD7A/Radical 7 V2 Radio Equipment Testing Standards Specification Method FCC 15.207:2014 ANSI C63.10:2009 FCC 15.247:2014 ANSI C63.10:2009 Results Method Clause Test Description Applied Results Comments 6.2 AC Powerline Conducted Emissions Yes Pass 6.5, 6.6 Spurious Radiated Emissions Yes Pass 6.7 Spurious Conducted Emissions Yes Pass 6.7 Band Edge Compliance Yes Pass 6.9.1 Occupied Bandwidth Yes Pass 6.10.2 Output Power Yes Pass 6.11.2 Power Spectral Density Yes Pass 7.5 Duty Cycle Yes N/A Characterization of radio operation. Deviations From Test Standards None Approved By: Victor Ratinoff, Operations Manager REV 2012.08.02 REVISION HISTORY Revision Number Description Date Page Number 00 None Barometric Pressure The recorded barometric pressure has been normalized to sea level. REV 2014.08.11 ACCREDITATIONS AND AUTHORIZATIONS United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC Guide 65 as a product certifier. This allows Northwest EMC to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada IC - Recognized by Industry Canada as a Certification Body (CB). Certification chambers and Open Area Test Sites are filed with IC. European Union European Commission – Validated by the European Commission as a Conformity Assessment Body (CAB) under the EMC directive and as a Notified Body under the R&TTE Directive. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIP / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFTA – Recognized by OFTA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. SCOPE For details on the Scopes of our Accreditations, please visit: http://www.nwemc.com/accreditations/ REV 2013.03.8 MEASUREMENT UNCERTAINTY Measurement Uncertainty When a measurement is made, the result will be different from the true or theoretically correct value. The difference is the result of tolerances in the measurement system that cannot be completely eliminated. To the extent that technology allows us, it has been our aim to minimize this error. Measurement uncertainty is a statistical expression of measurement error qualified by a probability distribution. A measurement uncertainty estimation has been performed for each test per our internal quality document WP 342. The estimation is used to compare the measured result with its "true" or theoretically correct value. The expanded measurement uncertainty (K=2) for each test is listed below. Our measurement data meets or exceeds the measurement uncertainty requirements of the applicable specification; therefore, the test data can be compared directly to the specification limit to determine compliance. The calculations for estimating measurement uncertainty are based upon ETSI TR 100 028 (or CISPR 16-4-1 as applicable), and are available upon request. The following table represents the Measurement Uncertainty (MU) budgets for each of the tests that may be contained in this report. Test + MU - MU Frequency Accuracy (Hz) 0.12 -0.01 Amplitude Accuracy (dB) 0.49 -0.49 Conducted Power (dB) 0.41 -0.41 Radiated Power via Substitution (dB) 0.69 -0.68 Temperature (degrees C) 0.81 -0.81 Humidity (% RH) 2.89 -2.89 Field Strength (dB) 3.80 -3.80 AC Powerline Conducted Emissions (dB) 2.94 -2.94 REV 2013.06.28 FACILITIES Oregon Labs EV01-12 22975 NW Evergreen Pkwy Hillsboro, OR 97124 (503) 844-4066 California Labs OC01-13 41 Tesla Irvine, CA 92618 (949) 861-8918 New York Labs NY01-04 4939 Jordan Rd. Elbridge, NY 13060 (315) 685-0796 Minnesota Labs MN01-08 9349 W Broadway Ave. Brooklyn Park, MN 55445 (763) 425-2281 Washington Labs NC01-05,SU02,SU07 19201 120 th Ave. NE Bothell, WA 98011 (425) 984-6600 VCCI A-0108 A-0029 A-0109 A-0110 Industry Canada 2834D-1, 2834D-2 2834B-1, 2834B-2, 2834B-3 2834E-1 2834F-1 NVLAP NVLAP Lab Code: 200630-0 NVLAP Lab Code: 200676-0 NVLAP Lab Code: 200761-0 NVLAP Lab Code: 200881-0 NVLAP Lab Code: 200629-0 WTD 13.9.30 PRODUCT DESCRIPTION Client and Equipment Under Test (EUT) Information Company Name: Masimo Corporation Address: 40 Parker City, …

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